CurrentBlue Cross Blue Shield - NebraskaPolicy M.86

MA Specialty Testing: Transplant (Preauthorization Required)

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Defines medical necessity and investigational criteria for donor-derived cell-free DNA and gene expression panel tests used in evaluation and monitoring of solid organ transplant recipients; applies to providers submitting preauthorization requests to Blue Cross Blue Shield - Nebraska.

Policy Summary

PayerBlue Cross Blue Shield - Nebraska

PolicyMA Specialty Testing: Transplant (Preauthorization Required)

Policy CodePolicy M.86

Change TypeNo material change

Effective DateMay 1, 2026

Next Review DateJan 1, 2027

Key ActionObtain preauthorization and include CPT/HCPCS or proprietary test codes when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentBlue Cross Blue Shield - NebraskaPolicy M.86

MA Specialty Testing: Transplant (Preauthorization Required)

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Sign up for Blue Cross Blue Shield - Nebraska Policy M.86 alerts

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Policy Summary

PayerBlue Cross Blue Shield - Nebraska

PolicyMA Specialty Testing: Transplant (Preauthorization Required)

Policy CodePolicy M.86

Change TypeNo material change

Effective DateMay 1, 2026

Next Review DateJan 1, 2027

Key ActionObtain preauthorization and include CPT/HCPCS or proprietary test codes when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

medically necessaryCoverage stance (solid organ dd-cfDNA)

not reasonable/necessaryBroad investigational stance

18+AlloMap age restriction

preauth requiredAdministrative requirement

investigationalLung transplant tests

Coverage Criteria for Specialty Transplant Tests

Evidence-Based Donor-Derived Cell-free DNA for Solid Organ Transplant Rejection

Covered when ALL of the following are met

General prerequisite: Peripheral blood dd-cfDNA has not been performed in the past 12 months12 months

(required)

Organ-specific testing (one required): One of the organ-specific branches below must be met

See children

Heart transplant branch: Member has undergone heart transplantation AND the test performed is AlloSure or Prospera

(meets organ-specific test requirement)

Kidney transplant branch: Member has undergone kidney transplantation AND the test performed is one of AlloSure, Prospera, Viracor TRAC Kidney dd-cfDNA, VitaGraft Kidney 2.0, VitaGraft Kidney Baseline, or VitaGraft Kidney Subsequent

(meets organ-specific test requirement)

Lung transplant branch: Member has undergone lung transplantation AND the test performed is AlloSure or Prospera

(meets organ-specific test requirement)

Clinical indications (at least one required): Member has clinical signs of acute rejection OR a biopsy performed to evaluate rejection was inconclusive OR the member is being monitored for adequacy of immunosuppression

These indications apply across organ branches

Post Heart Transplant Gene Expression Panels for Rejection Risk via Peripheral Blood

Covered when ALL of the following are met

Age: Member is age 18 or older>=18 years

(required)

Transplant status: Member has undergone heart transplant

(required)

Risk level: Member is at low-risk for organ rejection

(required)

Timing since transplant: Heart transplant was performed at least 2 months ago and less than 5 years ago>=2 months and <5 years

Coverage stance and guideline context

Policy-level coverage stance and referenced guideline contexts

Investigational for lung transplant: Donor-derived cell-free DNA tests with insufficient evidence of clinical validity in the management of patients after lung transplantation are considered investigational for all indications.

(policy stance)

Guideline-supported uses: Professional societies provide conditional recommendations: ASTS recommends dd-cfDNA may be used to rule out subclinical rejection in heart transplant recipients and recommends serial dd-cfDNA in kidney transplant though optimal frequency is unknown; ESOT suggests serial plasma dd-cfDNA to exclude subclinical antibody-mediated rejection in stable kidney grafts and to measure dd-cfDNA in acute graft dysfunction to exclude rejection.

(guideline summary)

CMS MolDX permitted uses: CMS LCD permits molecular testing when a transplant-center-affiliated physician is considering active rejection (particularly when biopsy is contraindicated) and specifies intended uses including assessing adequacy of immunosuppression, as a rule-out test for active rejection, further evaluation after physician-assessed pretest, or when biopsy is inconclusive.

(CMS LCD)

Peripheral blood donor-derived cell-free DNA (dd-cfDNA) testing for indications not explicitly listed in the medically necessary criteria is considered not reasonable and necessary. The policy requires that dd-cfDNA testing must meet the specified coverage criteria (including that dd-cfDNA has not been performed in the prior 12 months and that the test and clinical scenario match an approved organ-specific branch) — requests outside those scenarios may be denied.

Post–heart transplant gene expression panels performed on tissue specimens are considered not reasonable and necessary for all indications. The policy only designates peripheral blood GEP (e.g., AlloMap) as medically necessary under narrow adult post‑heart transplant criteria; tissue‑based GEP is excluded from coverage.

Donor‑derived cell‑free DNA tests for lung transplant recipients that lack sufficient evidence of clinical validity are considered investigational and will be denied for all indications. The policy specifies that dd‑cfDNA tests with inadequate validation in lung transplant management do not meet coverage thresholds.

Tests that do not have established clinical utility or validity as defined by the Concert general approach to genetic and molecular testing are excluded from coverage. The policy cites the absence of independent technology assessments or evidence‑based guideline support as a basis for non‑coverage of referenced tests that fail to meet those standards.

Peripheral blood dd‑cfDNA testing for solid organ transplant is considered investigational/not reasonable and necessary when the specific medical necessity criteria in this policy are not met. Coverage requires meeting all enumerated prerequisites (including no dd‑cfDNA in the prior 12 months, appropriate organ/test pairing, and an applicable clinical indication such as signs of acute rejection, inconclusive biopsy, or monitoring immunosuppression).

dd‑cfDNA tests for lung transplant management are deemed investigational due to insufficient evidence of clinical validity in this population. The policy references emerging evidence and aligns with CMS and professional guidance in limiting coverage where validity is not established.

Candidate and Organ-Specific Criteria

Candidate criteria for dd-cfDNA

dd-cfDNA testing candidate criteria by organ

Heart dd-cfDNA candidate: Heart transplant recipient AND AlloSure or Prospera test AND at least one clinical indication (clinical signs of acute rejection OR inconclusive biopsy OR monitoring for adequate immunosuppression)Not performed in past 12 months

dd-cfDNA not performed in past 12 months required

Kidney dd-cfDNA candidate: Kidney transplant recipient AND test is one of AlloSure, Prospera, Viracor TRAC Kidney dd-cfDNA, VitaGraft Kidney 2.0, VitaGraft Kidney Baseline, or VitaGraft Kidney Subsequent AND at least one clinical indication (clinical signs of acute rejection OR inconclusive biopsy OR monitoring for adequate immunosuppression)Not performed in past 12 months

dd-cfDNA not performed in past 12 months required

Post-Transplant Specific Coverage Rules

AlloMap peripheral blood gene expression panel — AlloMap (peripheral blood GEP)

ServiceAlloMap (peripheral blood gene expression panel)

Covered populationLow‑risk adult heart transplant recipients (age ≥18)

Timing windowPerformed between 2 months and less than 5 years after heart transplant

Coverage requirementUsed to determine management of patients after heart transplantation when other criteria met

Serial dd‑cfDNA testing when used for surveillance in absence of guideline‑specified frequency

Default surveillance frequencyOnce every 12 months when serial dd‑cfDNA is used for surveillance and guideline frequency is not specified

Coding and Billing Codes

Referenced transplant test CPT/HCPCS/PLA codesmixed

0118U	Viracor TRAC Heart/Kidney dd-cfDNA (Eurofins Transplant Genomics)
0493U	Prospera (Natera)
0540U	AlloSure (CareDx)
0055U	myTAIHEART (TAI Diagnostics)
0508U	VitaGraft Kidney Baseline + 1st Plasma Test (Oncocyte)
0509U	VitaGraft Kidney Subsequent (Oncocyte)
0544U	VitaGraft Kidney 2.0 (Oncocyte)
81595	AlloMap (post heart transplant gene expression panel)
0087U	Molecular Microscope MMDX - Heart (Kashi Clinical Laboratories)
81479	Unlisted molecular pathology procedure

Example diagnosis/aftercare codes referencedICD-10

T86.11	Heart transplant complication code (example listed)
T86.12	Kidney transplant complication code (example listed)
T86.810	Lung transplant complication code (example listed)
Z48.21	Encounter for aftercare following heart transplant
Z48.24	Encounter for aftercare following lung transplant
Z94.1	Heart transplant status
Z94.2	Lung transplant status

Example diagnosis/aftercare codes referencedICD-10

T86.11	Heart transplant complication code (example listed)
T86.12	Kidney transplant complication code (example listed)
T86.810	Lung transplant complication code (example listed)
Z48.21	Encounter for aftercare following heart transplant
Z48.24	Encounter for aftercare following lung transplant
Z94.1	Heart transplant status
Z94.2	Lung transplant status

Enumerated transplant molecular and PLA codesmixed

0055U	CARD HRT TRNSPL 96 TARGET DNA SEQUENCES PLASMA
0087U	CARD HRT TRNSPL MRNA GEN XPRS PRFL 1283 GENE ALG
0118U	TRANSPLANTATION MED QUAN DON-DRV CLL-FR DNA PLSM
0493U	TRNSPLJ MED QUANTIFICATION DDCFDNA NGS PLASMA
0508U	TRNSPLJ MED QUAN DDCFDNA 40 SNPS PLASMA&URINE
0509U	TRNSPLJ MED QUAN DDCFDNA
0540U	TRNSPLJ MEDICINE QUAN DD-CFDNA NGS ALYS PLASMA
81479	UNLISTED MOLELCULAR PATHOLOGY PROCEDURE
81595	CARDIOLOGY HRT TRNSPL MRNA GENE EXPRESS 20 GENES

dd‑cfDNA testing interval

RequirementPeripheral blood dd‑cfDNA has not been performed in the past 12 months

ContextRequired as a prerequisite for coverage consideration of dd‑cfDNA testing

Documentation notePrior dd‑cfDNA testing history should be included in prior authorization/records

AlloMap age and timing

Age requirementMember is age 18 years or older

Timing since transplantTest performed at least 2 months and less than 5 years after heart transplant

Provider Requirements and Actions

Prior Authorization

Preauthorization required for specialty transplant tests

Preauthorization is required before performing specialty transplant molecular tests referenced in this policy; include the CPT/HCPCS or proprietary test code(s) (for example: 0118U, 0493U, 0540U, 0055U, 0508U, 0509U, 0544U, 81595, 0087U, 81479) when submitting an authorization request.

Request must be submitted prior to testing.
List the specific test name and code(s) on the authorization request.

Prior Authorization

Preauthorization required for listed molecular/CPT-PLA codes

Preauthorization is required for the listed transplant-related molecular and CPT-PLA codes (examples include 0055U, 0087U, 0118U, 0493U, 0508U, 0509U, 0540U, 81479, 81595) prior to testing.

Provide the specific code(s) from the policy when requesting authorization.
Coverage determination will reference the enumerated CPT-PLA and molecular procedure codes.

Evaluation and Documentation Requirements

Documentation Required

Include prior biopsy, clinical signs, and dd-cfDNA history

Evaluation for coverage should include prior biopsy results, current clinical signs or symptoms of rejection, and the history of prior dd-cfDNA testing (confirming no dd-cfDNA within the past 12 months).

Document prior biopsy results and whether biopsy was inconclusive.
Document clinical signs consistent with acute rejection if present.

Documentation Required

Ensure intended use aligns with CMS MolDX LCD

Intended use submitted for testing should align with CMS MolDX LCD criteria — examples include assessment of immunosuppression adequacy, using the test as a rule-out for active rejection in validated populations, further evaluation after a physician-assessed pretest, or assessment when biopsy is inconclusive.

State which CMS-permitted intended use applies when ordering under MolDX guidance.

Transplant Center and Ordering Clinician Context

Note

No center accreditation/volume requirements specified

No explicit transplant center accreditation, volume, or other center-specific requirements are stated in this portion of the policy.

Documentation Required

Ordering should reflect transplant‑center‑affiliated physician assessment

When following the CMS MolDX LCD, testing should be considered in the context of a transplant‑center‑affiliated physician’s assessment, implying involvement of the transplant center or affiliated clinician in the decision to order molecular testing.

Include documentation that a transplant‑center‑affiliated physician assessed the patient when applicable.

Note

CMS LCD supports ordering when physician considers active rejection

CMS MolDX supports ordering molecular tests when a transplant‑center‑affiliated physician is considering active rejection, particularly in patients with significant contraindications to invasive biopsy.

Contraindications and Limitations

This policy does not specify any absolute or relative contraindications to peripheral blood dd‑cfDNA testing. Decisions about test appropriateness should follow the medical necessity criteria rather than contraindication rules.

CMS MolDX LCD supports molecular testing particularly when a transplant‑center‑affiliated physician is considering active rejection and especially in patients with significant contraindications to invasive procedures (for example, when biopsy is contraindicated). The policy references these CMS intended uses when aligning permitted clinical scenarios.

Definitions

dd‑cfDNA

Definition (short)Donor‑derived cell‑free DNA measured in recipient peripheral blood used to detect graft injury or rejection

SpecimenRecipient peripheral blood (plasma)

PurposeNoninvasive detection/monitoring of allograft injury or rejection

GEP (gene expression panel)

DefinitionPeripheral blood gene expression profiling (e.g., AlloMap) used to stratify post‑heart transplant rejection risk

Typical useIdentify low‑risk adult heart recipients to reduce endomyocardial biopsy frequency

Specimen

Background

Donor‑derived cell‑free DNA (dd‑cfDNA) testing measures circulating graft‑derived DNA in the recipient's peripheral blood and can be used to noninvasively detect allograft injury or rejection. Gene expression panels (GEP) such as AlloMap are peripheral blood assays used to stratify rejection risk after heart transplantation. The policy frames dd‑cfDNA and GEP as tools to assist evaluation of immunosuppression adequacy, to help rule out active rejection in validated populations, or to further evaluate graft status when biopsy is inconclusive.

Policy Summary

PayerBlue Cross Blue Shield - Nebraska

PolicyMA Specialty Testing: Transplant (Preauthorization Required)

Policy CodePolicy M.86

Change TypeNo material change

Effective DateMay 1, 2026

Next Review DateJan 1, 2027

Key ActionObtain preauthorization and include CPT/HCPCS or proprietary test codes when requesting authorization.

SourceLink

On This Page

Tests lacking established utility not covered: Tests that lack established clinical utility or validity per the Concert policy and without independent technology assessment or evidence-based guideline support do not meet the threshold for coverage.

(policy basis for non-coverage)

Lung dd-cfDNA candidate: Lung transplant recipient AND AlloSure or Prospera AND at least one clinical indication (clinical signs of acute rejection OR inconclusive biopsy OR monitoring for adequate immunosuppression)Not performed in past 12 months

dd-cfDNA not performed in past 12 months required

Organ-specific guidance summary

Professional society recommendations summarized

Heart transplant: ASTS recommends dd-cfDNA may be utilized to rule out subclinical rejection for heart transplant recipients; ISHLT supports peripheral blood gene expression profiling (e.g., AlloMap) as an option to identify low-risk adult heart recipients between 2 months and 5 years post-transplant.

(ASTS, ISHLT summary)

Kidney transplant: ASTS suggests serial dd-cfDNA testing though the optimal surveillance frequency is unknown; ESOT suggests measuring serial plasma dd-cfDNA in patients with stable graft function to exclude subclinical antibody-mediated rejection and measuring dd-cfDNA in acute graft dysfunction to exclude rejection.

(ASTS, ESOT summary)

Lung transplant: Professional society evidence is insufficient to support dd-cfDNA testing for lung transplant rejection; such tests are considered investigational.

(policy/guideline alignment)

RationaleAdopted in absence of clear, specific, evidence‑based guideline recommendations for a testing regimen

Guideline contextASTS and ESOT mention serial dd‑cfDNA but do not define an optimal frequency; default adopted per Concert note

Test modalityPeripheral blood gene expression profiling (AlloMap)

Default surveillance frequency

Default frequencyOnce every 12 months

Applies whenSerial dd‑cfDNA surveillance lacks guideline‑specified frequency

Adoption noteConcert policy adopts this default in absence of explicit recommendations

Step Therapy

Step therapy not specified

Not applicable — this policy does not specify any step therapy sequencing or prerequisite therapeutic steps prior to authorization of the referenced tests.

Documentation Required

Required clinical documentation for authorization

Documentation submitted with authorization requests must confirm the transplanted organ, the specific test name and code (examples: AlloSure, Prospera, Viracor TRAC Kidney dd-cfDNA, VitaGraft variants, AlloMap), timing since transplant, that peripheral blood dd-cfDNA has not been performed in the prior 12 months, and the clinical indication (e.g., clinical signs of acute rejection, biopsy inconclusive for acute rejection, or monitoring for adequate immunosuppression).

Specify test name and CPT/PLA code.
Report time since transplant and whether dd-cfDNA was performed in past 12 months.
Provide clinical indication and prior biopsy results if applicable.

Documentation Required

Match intended use to CMS MolDX LCD permitted uses

When ordered under the CMS MolDX LCD, the intended use documented by the ordering clinician must match one of the CMS-permitted uses (for example: to assist evaluation of adequacy of immunosuppression as an alternative to biopsy; as a rule-out test for active rejection in validated populations; further evaluation after a physician-assessed pretest; or to assess rejection when a biopsy is inconclusive).

If relying on CMS MolDX LCD coverage, state the specific intended use that aligns with the CMS list.
Ensure testing is ordered in the context of a transplant-center-affiliated physician considering active rejection when applicable.

Denial Risk

Denial risk for non-covered dd-cfDNA indications

Requests for peripheral blood donor-derived cell-free DNA for indications that do not meet the policy’s medically necessary criteria (i.e., indications outside the listed organ/test/clinical scenarios) are considered not reasonable and necessary and may be denied.

Authorization should demonstrate the member meets the policy criteria (organ type, allowed test, clinical indication, and dd-cfDNA not performed within prior 12 months).

Denial Risk

Denial risk for tissue-based gene expression panels

Post–heart transplant gene expression panels performed on tissue (rather than peripheral blood) are considered not reasonable and necessary for all indications and may be denied.

Only peripheral blood GEP (e.g., AlloMap) within the specified adult post-transplant window is considered medically necessary per policy.

Denial Risk

Denial risk: investigational dd-cfDNA for lung transplant

Donor-derived cell-free DNA tests for lung transplant management are considered investigational due to insufficient evidence of clinical validity and will be denied for all indications.

Requests for dd-cfDNA to manage lung transplant patients should not be authorized under this policy.

Indicate if biopsy is contraindicated or if the test is being used in lieu of biopsy per CMS permitted uses.

Peripheral blood (mRNA expression panel)

dd‑cfDNA

Expanded descriptionQuantification of donor‑origin cell‑free DNA in recipient plasma, reported as percentage of total cell‑free DNA; performed by NGS or SNP‑based assays

ReportingReported as percentage of donor‑derived cfDNA of total cfDNA with interpretation related to risk of active rejection

MethodsNext‑generation sequencing (NGS) or targeted SNP panels (various proprietary assays)

Gene expression profiling (GEP)

DefinitionGene expression panel (GEP): Peripheral blood or tissue‑based mRNA expression profiling (e.g., AlloMap, MMDx) reported as a score estimating rejection risk

Example assaysAlloMap (peripheral blood), MMDx (molecular microscope) for tissue‑based profiling

OutputAlgorithm‑derived score estimating probability of rejection to inform clinical management